Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.
Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.
MES SDLC Validation Consultant
Location: (Remote) Maryland (MD), United States
Company:
You will work through Valspec at our client.
Job Overview:
We are looking for a skilled Validation Specialist to join our team as we prepare for the launch of our NetSuite implementation, integrated with a special data tool, which will serve as our Manufacturing Execution System (MES). The candidate will be responsible for ensuring full compliance with SOX regulations, validating a special data tool, and appropriate interfaces to NetSuite. This role is crucial for meeting our go-live date.
Responsibilities: Perform a gap assessment against our established Computer System Validation (CSV) framework. Validate special data tool and ensure its seamless integration with Oracle NetSuite. Ensure SOX compliance for all relevant systems and interfaces. Execute and document all validation activities, including SDLC package reviews (RA, URS, FRS, DS, RTM, IQ/OQ/PQ, and Summary Report). Collaborate with the vendor to review and utilize their provided SDLC package. Prepare comprehensive validation documentation and summary reports.
Qualifications:
Proven experience in validating software systems in a regulated environment, preferably in the biotechnology or pharmaceutical industry. Strong understanding of Computer System Validation (CSV) principles and SOX compliance requirements. Experience with Oracle NetSuite and MES systems. Excellent documentation and communication skills. Ability to work collaboratively with cross-functional teams and external vendors.
Preferred Qualifications:
Previous experience in the cell and gene therapy field. Familiarity with the FDA regulatory environment.
Employment Type:
Contract – 6 months (W2 or 1099)
Benefits:
Competitive salary and benefits package if W2 is chosen. Opportunity to work in a dynamic and innovative environment. Contribution to cutting-edge cell and gene therapy advancements.
Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives.Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.Valspec is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.
